The standardization in Egypt is coordinated by the Ministry of Health and Population (MOHP), through the Drug Policy and Planning Center (DPPC) and the Central Administration of Pharmaceutical Affairs (CAPA). The DPPC also controls the importation and manufacturing of the medical devices and instruments through a specialized committee that comprises of leading professors with specialties in various medical fields along with experts of medical engineering. Egypt has adopted the European Risk Classification System for medical devices (Class I, IIa, IIb, III).

A local agent is not required by the Egyptian authorities, but due to the complicated registration process most companies find it beneficial to engage a local agent to take care of the bureaucratic procedures and any communication issues.  Our country specific (*) regulatory services in Egypt include:

Medical Device specific regulation strategy reports, Medical Device Registration with Egypt CAPA, Egyptian Representative and certification holder for Medical Device manufacturers, Egypt CAPA Technical documents preparation and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Egypt!

(*) Egyptian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.